MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION ENTRADA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-4200
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that post intravenous sedation, the patients procedure was aborted as there was something wrong with the tip of needle and it was preventing the physician from accessing the epidural space.The patient was reportedly doing well.
Additional Manufacturer Narrative
Sc-4200.The returned insertion needle was analyzed, and visual inspection revealed that the tip of the needle is deformed.With all the available information, boston scientific concludes: the reported event was confirmed.It appears that excessive mechanical force was exerted onto the tip of the needle during the procedure resulting in its deformation.The probable cause selected is unintended use error caused or contributed to event.
Event or Problem Description
It was reported that post intravenous sedation, the patients procedure was aborted as there was something wrong with the tip of needle and it was preventing the physician from accessing the epidural space.The patient was reportedly doing well.

• Brand Name: ENTRADA
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16042379
• Report Number: 3006630150-2022-07243
• Device Sequence Number: 6437678
• Product Code: LGW
• UDI-Device Identifier: 08714729121442
• UDI-Public: 08714729121442
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/28/2023
• Device Model Number: SC-4200
• Device Catalogue Number: SC-4200
• Device Lot Number: 27164573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown